Evaluation of the Effectiveness of a Multimedia Information Site in Reducing Preoperative Anxiety in Vascular Surgery Patients.

NCT05717296 | Completed

• 1 other identifier: 2022-A00664-39
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Anxiety is a phenomenon that frequently occurs before surgery. Preoperative anxiety has been studied in several disciplines, including rheumatology, anesthesia, stomatology and cardiology. The implications of preoperative anxiety in terms of morbidity and mortality have also been studied and are well known: intraoperative hemodynamic disorders, increased postoperative mortality, increased consumption of anesthetic agents. Several scales have been developed to quantify preoperative anxiety, the most frequently used being the visual analog scale and the Amsterdam scale. Several approaches have been considered to reduce preoperative anxiety, such as hypnosis, music, or multimedia. However, no consensus tool has been developed for vascular surgery patients. Similarly, no study has examined preoperative anxiety in this specific population. The aim of this study is to evaluate a new multimedia information medium for vascular surgery patients and to assess its effectiveness in reducing preoperative anxiety.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluation of the evolution of preoperative anxiety in patients with access to multimedia with the help of a numerical scale compared to the group of patients without multimedia support

  The patient rates his anxiety between 0 and 10: 0 no anxiety; 10 maximum anxiety

  Day 0 ; Day 1 ; Day before the surgery

Secondary Outcomes (1)

• Assessment of satisfaction with the multimedia support using a 4-point scale: 1) Very satisfied ; 2) Satisfied ; 3) Not very satisfied ; 4) Not satisfied

  Day before the surgery

Study Arms (2)

with multimedia support

EXPERIMENTAL

Other: anxiety survey; Other: scale of satisfaction; Other: Multimedia Information

without multimedia support

SHAM COMPARATOR

Other: anxiety survey

Interventions

anxiety survey OTHER

surgery and anesthesia anxiety questionnaire

with multimedia support; without multimedia support

scale of satisfaction OTHER

scale of satisfaction of multimedia

with multimedia support

Multimedia Information OTHER

Patients randomized to the "with multimedia support arm "will have access to educational videos focused on the vascular surgery they are to receive.

with multimedia support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Patient affiliated to a health insurance plan
• French-speaking patient
• Patient who has given free, informed and express consent
• Patient who has consulted a vascular surgeon for a scheduled procedure
• Patient with internet and telephone access to view videos
• Patient referred for surgical or endovascular treatment for obliterative arteriopathy of the lower limbs, abdominal aortic aneurysm and surgical treatment for carotid stenosis

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection
• Patients with blindness
• Patients with severe cognitive impairment
• Patients without access to a digital support to view the videos
• Pregnant and breastfeeding women

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Groupe hospitalier Paris Saint Joseph-hopital Marie Lannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: February 8, 2023
• Study Start: June 29, 2022
• Primary Completion: June 29, 2023
• Study Completion: December 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (1)